U.S. FDA Food Safety Modernization Act (FSMA) for Customs Brokers

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Learn about the new regulations under the U.S. FDA Food Safety Modernization Act (FSMA), including new requirements for U.S. Agents.

Learn about the new regulations under the U.S. FDA Food Safety Modernization Act (FSMA), including new requirements for U.S. Agents.

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  • 1. U.S. FDA Food SafetyModernization Act: Are you Ready? Presented by Cornelia Rooks, Senior Regulatory Specialist Registrar Corp August 2012 11/01/12
  • 2. FDA Food Safety Modernization Act“FSMA” signed by President Obama 01/04/2011Phased in over time thru 2016Most significant update to food safety laws since 1938
  • 3. Motivators for FSMAAbout 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food borne diseasesPublic health burden that is largely preventable.
  • 4. High Profile CasesImports in the spotlight Melamine in pet food Illegal antibiotics in aquaculture Better detection of common pathogens, and strains of new pathogens.
  • 5. Imports of FDA-Regulated Food Have Almost Doubled Since 2002
  • 6. Burden on Manufacturers and ImportersPort-of-Entry inspection cannot handle increase in imported foodsFSMA makes Importers more responsible for quality of products from foreign manufacturers
  • 7. Vision of FSMA Prevention Inspections, Enhanced Compliance,Partnerships and Response Import Safety
  • 8. NEW FDA REQUIREMENTS CURRENTLY IN EFFECT
  • 9. Latest Developments New User Fees- Registration Suspension Administrative Detentions Updated Prior Notice Filings Anti-Smuggling New Dietary Supplements guidance Processed foods and produce pilots to explore how to quickly trace foods back to source of contamination-
  • 10. Registration RenewalEach food facility must renew its U.S. FDA registration every two years (4th quarter of every even-numbered year). Starting October 2012Low acid and acidified food manufacturers typically must have two separate FDA registrations for each location, • (1) a Food Facility Registration (“FFR”), which all food facilities must file, regardless of whether they handle low acid and acidified foods, and • (2) a Food Canning Establishment (“FCE”) registration.Note: An Update to electronic system on 8/1/12, for new companies entering data into systemThe data in these two registrations must match precisely.
  • 11. United States Agent  Foreign Establishments must notify FDA of the name, business name, address, phone number, and email address of their United States agent.  The US Agent must reside or maintain a place of business in the US.
  • 12. United States AgentU.S. Agents have been designated since 2003, and foreign companies have not had to update that information since the initial designationSince 2003, many customs brokers and importers have allowed foreign companies to designate them as the required “U.S. Agent”
  • 13. New FDA User FeesNew FDA User Fees Effective October 1, 2011FDA Hourly Rate For Reinspections and Reconditioning:  $221 per hour, domestic  $289 per hour for foreign travelRevision Announced August 1, 2012, effective October 1, 2012
  • 14. FSMA Reinspection FeesInvoiced to the foreign facility’s designated “U.S. Agent”That could be an importer who agreed to act as the U.S. AgentThat could be YOU ----- if you have been designated as the “U.S. Agent” by a foreign food facility’s FDA registration
  • 15. Reinspection“Reinspection” is one or more inspections subsequent to such an inspection which identified non-compliance materially related to a food safety requirement.
  • 16. New FDA User FeesReinspection Fees Fee is based on the number of direct hours, including: time spent conducting the physical surveillance at the facility, whatever components of such an inspection are deemed necessary making preparations and arrangements for the reinspection
  • 17. New FDA User FeesReinspection Fees traveling to and from the facility preparing any reports, analyzing any samples examining any labels if required performing other activities until the facility is in compliance.
  • 18. New FDA User Fees“Reconditioning Fees” on Imported Food Fees must be paid by owner of food or importer, depending on circumstances Fees must be paid at the hourly rate for all expenses in connection with arranging, conducting, and evaluating the results of examinations and additional examinations of product
  • 19. New FDA User Fees“Reconditioning Fees” on Imported Food. Will be charged where reconditioning is required to bring food into compliance Will be charged if product is destroyed
  • 20. Fees Related to Import Alerts (DWPE) Will be charged where food is detained by an Import Alert No charge if food is detained, not subject to an Import Alert, and Shipper or Importer submits satisfactory proof that food is not adulterated.
  • 21. Fees Related to Import Alerts (DWPE)Exporters applying for removal from DWPE must pay FDAs hourly charges for evaluating the application, including the cost of inspecting the foreign facility if necessary.
  • 22. New FDA User FeesNot Complying with a Recall Order (1) Not initiating a recall as ordered by FDA (2) Not conducting the recall in the manner specified by FDA (3) not providing FDA with information regarding the recall as ordered by FDA. An importer who does not comply with a recall order is responsible for paying the fee The party paying the fee would be the party that received the recall order.
  • 23. Other Recent Changes By FSMA Affecting CustomsBrokers, Freight Forwarders and Importers
  • 24. Prior Notice Filers need to indicate whether a food product has been refused entry to another country
  • 25. Registration SuspensionFDA’s power to suspend the registration of food facilities effectively closes any facility that created, caused, or is responsible for food having a reasonable probability of adverse health consequences to humans or animals.FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States.
  • 26. Registration SuspensionRegistration may be held in suspension until U.S. FDA determines the cause to be rectified and that no further health consequences exist.FDA also announced its right to require “corrective action plans” from suspended facilities as proof that no further health consequences exist.
  • 27. Administrative DetentionAllows FDA to proactively halt food suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern.If FDA suspects food to have been produced or processed in unsanitary conditions, the agency may administratively detain food products for up to 30 days.
  • 28. Import SafetyVoluntary Qualified Importer Program(VQIP) Implementation was due June 2012 FDA must establish a user-fee funded VQIP to expedite entry into the United States of imported food from eligible, qualified importers. To be eligible to participate, an importer must offer food for importation from a facility that has a certification by an accredited third party. FDA will qualify eligible importers to participate in VQIP based on risk considerations. The new law directs FDA to issue guidance on participation in and compliance with VQIP.
  • 29. Import SafetyForeign Supplier Verification Program (FSVP) Regulation was due January 2012 FSVP requires all importers to conduct risk-based foreign supplier verification activities to verify that imported food is not adulterated and that it was produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable.
  • 30. FSMA and Inspections 11/01/12
  • 31. FDA Registered FacilitiesDomestic registrations: 169,884Foreign registrations: 445,884Total: 615,768**As of May 22, 2012
  • 32. Inspections and DetentionsU.S. FDA’s review of a facility or product can have serious impact on business
  • 33. Reasons for InspectionRoutine scheduleSurveyResponse to reported problemFulfillment of FSMA mandate
  • 34. FDA’s Foreign Inspection History
  • 35. FDA’s 2010 Foreign Inspection Totals
  • 36. FSMA Foreign Facility Inspection ScheduleDouble the previous year, minimum of: Year Foreign Inspections 2011 600 2012 1,200 2013 2,400 2014 4,800 2015 9,600 2016 19,200 11/01/12
  • 37. One Big Challenge…
  • 38. Detentions
  • 39. Shipment Detained?Shipment arrives, FDA has options: 1. Release 2. Detain –Review – Release 3. Detain – Review – Test – Release 4. Detain – Review – Test – Refuse entryPhone call in the nightIf importer advises you of detention, ask for a copy of the “Notice of FDA Action.”
  • 40. Compliance IssuesMisbranding: FDA has jurisdiction to ensure that food labeling is truthful, non-misleading, and adequate to ensure that foods are safe and effective for their intended uses.Adulteration: FDA has jurisdiction to ensure that foods are properly processed, meet their specifications and are not contaminated.
  • 41. Analysis of FDA Detentions
  • 42. Common Reasons for DetentionFailure to label product correctly – Most of these detentions could have been avoided by pre-shipment label review.Failure to make required electronic filings – Registrations, Process Filings, Prior Notices…
  • 43. Food Labeling & IngredientsA top reason product is detained: Incorrect labeling, unapproved ingredients, prohibited health claimsEasy problems to avoidCommon errors in trying to avoid problems: Copy other wrong labels Only follow part of the regulations
  • 44. “Notice ofFDA Action”Example
  • 45. OASIShttp://www.accessdata.fda.gov/scripts/importrefusals
  • 46. FDA Automatic DetentionProducts from certain countries, foreign manufacturer, a specific product, or shipper may be placed on “Automatic Detention,” also called DWPE.Reasons may include: article has been manufactured, processed, or packed under insanitary conditions article is adulterated, misbranded
  • 47. Removal from FDA Automatic Detention/DWPENot easy: FDA must believe the issue(s) causing the listing have been resolved (i.e. what have you changed?);A minimum of five consecutive non-violative commercial shipments before the FDA will consider removal;Shipments should represent routine commercial entries and include certain documentation;A written petition with documentation must be submitted to FDA for their review/action
  • 48. Proactive versus Reactive Numerous regulations already exist U.S. offers enormous market potential and products will only need to comply with specific regulations, not all. Best advice: stay informed. Many changes are coming over the next 4 years. Investing in compliance is much cheaper than reacting to a failed inspection or detention in the U.S. Detentions mean demurrage, laboratory testing fees, warehousing fees, cost to “recondition” product, return freight, possible FDA fees, and loss of a customer.
  • 49. Compliance to U.S. FDA Regulations BEFORE first shipment to the U.S is much cheaper than a single detention. Think about the various costs of a detention: 1. Demurrage: $$$ per day 2. Laboratory testing fees: $$$ per sampling/test 3. Warehousing fees: $,$$$ ? 4. Freight cost to return the product: $,$$$ ? 5. Cost to “recondition” the product (re-label, for example): $,$$$ ? 6. Cost of loosing a client: $$$,$$$ ? 7. FDA Fees $$$?
  • 50. About Registrar CorpExpertise in Food & Beverages, Medical Devices, Cosmetics, Radiation Emitting Devices, and DrugsFounded in 2003, based in Hampton, Virginia, USA with over 100 employeesAll services are fixed fee, no hourly rates25,000 total clients served from more than 150 countries“Live Help” on web site19 overseas offices.
  • 51. Food & Beverage ServicesFDA Food Facility RegistrationsRegistration Renewals in 2012U.S. Agent ServiceFood Labeling ReviewsLow-Acid & Acidified Canned Food RegistrationsPrior Notice FilingsDetention AssistanceAudit Service starting October 2012
  • 52. Pre-Inspection Audit ServiceCOMING SOON • As part of our U.S. Agent service, Registrar Corp will dispatch a food safety expert trained in FDA inspections to facilities to help prepare if a notice of FDA inspection after October 1, 2012 is received. • This assistance is included at no additional charge other than travel and lodging expenses.
  • 53. Need Additional Assistance?US Agent and Detention Services Drug Products  Establishment Registration  Product Listing  Label & Ingredient Reviews  Drug Master Files (DMF) Medical Devices  Establishment Registration  Device Listings  510(k) Administrative Review  Medical Device Master Files (MAF)
  • 54. About Registrar Corp Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA 23666 P: +757-224-0177 F: +757-224-0179 E: info@registrarcorp.com
  • 55. Questions & Answersinfo@registrarcorp.com